Generic Drug Product Development: Specialty Dosage Forms

1st Edition

Leon Shargel, Isadore Kanfer

CRC Press
Published March 25, 2010
Reference - 288 Pages - 50 B/W Illustrations
ISBN 9780849377860 - CAT# DK7786
Series: Drugs and the Pharmaceutical Sciences

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Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives.

The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.

The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.


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